Biomarkers for monitoring intervention therapies for diabetes
AssigneeMerck Sharp & Dohme Corp.
InventorsHuseyin Mehmet, Sandra C. Souza, Hidehisa Asada, Yoshiaki Miura, Taku Nakahara, Diane McCarthy
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Abstract
The use of N-linked glycosylation pattern of serum proteins as a biomarker for evaluating the efficacy of intervention therapies for diabetes is disclosed. As disclosed herein, changes in the N-linked glycosylation of total plasma proteins precedes and predicts the decrease in glycated hemoglobin (HbA1c) associated with successful treatment of diabetes. Therefore, measuring changes in N-linked glycosylation of total serum plasma proteins over time may be used as a biomarker to evaluate or access the efficacy of an intervention therapy for diabetes.
Claims19
A method of determining the efficacy of an anti-diabetic therapy or treatment comprising:
- (a) determining the N-glycan composition of a serum sample obtained from an individual or patient at a time following the start of the anti-diabetic therapy or treatment;
- and
- (b) comparing the N-glycan composition of the serum sample to the N-glycan composition of a serum sample obtained from the individual or patient at a time before the start of the anti-diabetic therapy or treatment,
- wherein a difference between the N-glycan composition of the serum sample obtained from the individual or patient at a time following the start of the anti-diabetic therapy or treatment and the N-glycan composition of the serum sample obtained from the individual or patient at a time before the start of the anti-diabetic therapy or treatment indicates that the anti-diabetic therapy or treatment is efficacious.
A method of determining the efficacy of an anti-diabetic therapy or treatment comprising:
- (a) providing a first serum sample obtained from an individual or patient at a time before the start of the anti-diabetic therapy or treatment and a second serum sample obtained from the individual from a time following the start of the anti-diabetic therapy or treatment;
- (b) determining the N-glycan composition of the first serum sample to obtain a first N-linked glycosylation profile and determining the N-glycan composition of the second serum sample to obtain a second N-linked glycosylation profile;
- and
- (c) comparing the first and second N-linked glycosylation profiles, wherein a difference between the first and second N-linked glycosylation profiles indicates that the anti-diabetic therapy or treatment is efficacious.
19-21. (canceled)
Dependencies are inferred from the claim text.